Choline supplementation in children with fetal alcohol spectrum disorders has high feasibility and tolerability

Wozniak, Jeffrey R.; Fuglestad, Anita J.; Eckerle, Judith K.; Kroupina, Maria; Miller, Neely C.; Boys, Christopher J.; Brearley, Ann M.; Fink, Birgit A.; Hoecker, Heather L.; Zeisel, Steven H.; Georgieff, Michael

doi:10.1016/j.nutres.2013.08.005

Cited by 59 publications

(53 citation statements)

References 38 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Ninety-five percent of participants completed treatment with a compliance rate of 96%. These rates are consistent with those of previous studies (14,16) and further support that choline supplementation is feasible and tolerable in children with FASDs.…”

Section: Discussionsupporting

confidence: 91%

“…On the basis of expected medium effect sizes (Cohen's d = 0.29-0.42) that were observed in early phase I analyses by Wozniak et al (16), we calculated that a total sample size of w50 subjects would be needed for 80% power to detect significant differences between treatment groups with an a level of P , 0.05. Individuals were recruited through the following 2 primary sites: the Center for Behavioral Teratology at San Diego State University and Double ARC, which is a nonprofit organization providing services to families of children with FASDs in Toledo, Ohio.…”

Section: Participantsmentioning

confidence: 99%

See 1 more Smart Citation

Randomized, double-blind, placebo-controlled clinical trial of choline supplementation in school-aged children with fetal alcohol spectrum disorders

Nguyen

Risbud

Mattson

et al. 2016

The American Journal of Clinical Nutrition

View full text Add to dashboard Cite

Background: Prenatal alcohol exposure results in a broad range of cognitive and behavioral impairments. Because of the long-lasting problems that are associated with fetal alcohol spectrum disorders (FASDs), the development of effective treatment programs is critical. Preclinical animal studies have shown that choline, which is an essential nutrient, can attenuate the severity of alcohol-related cognitive impairments. Objective: We aimed to translate preclinical findings to a clinical population to investigate whether choline supplementation can ameliorate the severity of memory, executive function, and attention deficits in children with FASDs. Design: In the current study, which was a randomized, doubleblind, placebo-controlled clinical trial, we explored the effectiveness of a choline intervention for children with FASDs who were aged 5-10 y. Fifty-five children with confirmed histories of heavy prenatal alcohol exposure were randomly assigned to either the choline (n = 29) or placebo (n = 26) treatment arms. Participants in the choline group received 625 mg choline/d for 6 wk, whereas subjects in the placebo group received an equivalent dose of an inactive placebo treatment. Primary outcomes, including the performance on neuropsychological measures of memory, executive function, and attention and hyperactivity, were assessed at baseline and postintervention. Results: Compared with the placebo group, participants in the choline group did not differentially improve in cognitive performance in any domain. Treatment compliance and mean dietary choline intake were not predictive of treatment outcomes. Conclusions: Findings of the current study do not support that choline, administered at a dose of 625 mg/d for 6 wk, is an effective intervention for school-aged (5-10 y old) children with FASDs. This research provides important information about choline's therapeutic window. Combined with other studies of choline and nutritional interventions in this population, this study emphasizes a further need for the continued study of the role of nutritional status and supplementation in children with FASDs and the contributions of nutrition to neurocognition. This trial was registered at clinicaltrials.gov as NCT01911299.Am J Clin Nutr 2016;104:1683-92.

show abstract

Section: Discussionsupporting

confidence: 91%

Section: Participantsmentioning

confidence: 99%

Randomized, double-blind, placebo-controlled clinical trial of choline supplementation in school-aged children with fetal alcohol spectrum disorders

Nguyen

Risbud

Mattson

et al. 2016

The American Journal of Clinical Nutrition

View full text Add to dashboard Cite

show abstract

“…If doses of choline (as a nutraceutical, rather than just to correct a deficiency) need to be high (as used in the rodent studies), this may limit the feasibility in clinical settings due to tolerability. Currently, there is one study in children (aged 2–5 years old) with FASD that assessed tolerability and potential adverse effects associated with choline supplementation (Wozniak et al, 2013), but this information is not known for pregnant women.…”

Section: Discussionmentioning

confidence: 99%

“…The choline group was given a daily dose of 750 mg (~10 mg/kg per day), thus helping to guide the decision for the dose of choline used in the sheep model (Coles et al, 2015). Higher daily doses of choline (on a mg/kg basis) may be given postnatally in humans (Wozniak et al, 2013), but this sheep model was developed to test choline supplementation during pregnancy with binge-like alcohol exposure during the first-trimester equivalent. Consequently, the dosing regimen used in this sheep model is both relevant and highly translational in respect to dose of choline and timing outcome of the children postnatally.…”

Section: Methodsmentioning

confidence: 99%

Maternal choline supplementation in a sheep model of first trimester binge alcohol fails to protect against brain volume reductions in peripubertal lambs

Birch

Lenox

Kornegay

et al. 2016

Alcohol

View full text Add to dashboard Cite

Fetal alcohol spectrum disorder (FASD) is a leading potentially preventable birth defect. Poor nutrition may contribute to adverse developmental outcomes of prenatal alcohol exposure, and supplementation of essential micronutrients such as choline has shown benefit in rodent models. The sheep model of first-trimester binge alcohol exposure was used in this study to model the dose of maternal choline supplementation used in an ongoing prospective clinical trial involving pregnancies at risk for FASD. Primary outcome measures included volumetrics of the whole brain, cerebellum, and pituitary derived from magnetic resonance imaging (MRI) in 6-month-old lambs, testing the hypothesis that alcohol-exposed lambs would have brain volume reductions that would be ameliorated by maternal choline supplementation. Pregnant sheep were randomly assigned to one of five groups – heavy binge alcohol (HBA; 2.5 g/kg/treatment ethanol), heavy binge alcohol plus choline supplementation (HBC; 2.5 g/kg/treatment ethanol and 10 mg/kg/day choline), saline control (SC), saline control plus choline supplementation (SCC; 10 mg/kg/day choline), and normal control (NC). Ewes were given intravenous alcohol (HBA, HBC; mean peak BACs of ~280 mg/dL) or saline (SC, SCC) on three consecutive days per week from gestation day (GD) 4–41; choline was administered on GD 4–148. MRI scans of lamb brains were performed postnatally on day 182. Lambs from both alcohol groups (with or without choline) showed significant reductions in total brain volume; cerebellar and pituitary volumes were not significantly affected. This is the first report of MRI-derived volumetric brain reductions in a sheep model of FASD following binge-like alcohol exposure during the first trimester. These results also indicate that maternal choline supplementation comparable to doses in human studies fails to prevent brain volume reductions typically induced by first-trimester binge alcohol exposure. Future analyses will assess behavioral outcomes along with regional brain and neurohistological measures.

show abstract

“…In children whose mothers drank alcohol there are functional difficulties that are difficult to diagnose and classify, and often sensory integration dysfunction. For these children SI therapy is necessary and effective [10][11][12][13][14][15][16][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33]. This work, because of the breadth of statistical analysis, only shows the effects of SI therapy on gross motor function.…”

Section: Discussionmentioning

confidence: 99%

The impact of sensory integration therapy on gross motor function in children after prenatal exposure to alcohol

Wilczyński¹,

Zawada²

2015

View full text Add to dashboard Cite

Słowa kluczowe: fizjoterapia, integracja sensoryczna, dzieci po prenatalnej ekspozycji na alkohol. AbstractIntroduction: In Poland there are 900 cases of full-blown foetal alcohol syndrome (FAS) in neonates per year, and in 9000 children there are some symptoms of it. Aim of the research: To analyse the impact of sensory integration (SI) therapy on gross motor skills function in children after prenatal exposure to alcohol. Material and methods: The study was conducted on a group of 20 children aged 4-5 years with information from an interview about prenatal exposure to alcohol. The diagnosis of sensory integration disorder consisted of two 60-minute diagnostics meetings. Twelve trials with clinical observations were performed by Ayres: finger to nose, cocontraction, prone extension posture, flexed position supine, asymmetrical tonic neck reflex (ATOS), symmetrical tonic neck reflex (STOS), muscle tension, Schilder test, dynamic balance, static balance, gravitational insecurity, and trunk stabilisation. The therapeutic program included: normalisation of the vestibular and proprioceptive system, normalisation of the touch system, strengthening muscle tension, development of motion planning, development of oculomotor performance, development of motor coordination, hand therapy, integration of ATOS, STOS, development of locomotion and balance functions, and improving efficiency of gross and small motor skills. Results and conclusions: High efficiency of SI therapy has been shown in children after prenatal exposure to alcohol on the example of gross motor skills. Positive effects of SI therapy have been shown for tests: finger to nose, in the erect position on the stomach, the flexural position on the back, ATOS, STOS, Schilder test, dynamic balance, static balance, and the uncertainty of gravity and trunk stabilisation. Only cocontraction and muscle tension tests showed no efficacy of SI therapy. The a-Cronbach position analysis showed high reliability of the performed tests both before and after the therapy. It is advisable to continue the study on a larger sample and observation of the functional status of children after therapy.

show abstract

Choline supplementation in children with fetal alcohol spectrum disorders has high feasibility and tolerability

Cited by 59 publications

References 38 publications

Randomized, double-blind, placebo-controlled clinical trial of choline supplementation in school-aged children with fetal alcohol spectrum disorders

Randomized, double-blind, placebo-controlled clinical trial of choline supplementation in school-aged children with fetal alcohol spectrum disorders

Maternal choline supplementation in a sheep model of first trimester binge alcohol fails to protect against brain volume reductions in peripubertal lambs

The impact of sensory integration therapy on gross motor function in children after prenatal exposure to alcohol

Contact Info

Product

Resources

About